Postpartum hemorrhage, defined as excessive blood loss after birth, is the leading cause of maternal death in the world, claiming the lives of over 125,000 mothers every year. Inability to control postpartum bleeding can require a woman to receive multiple blood transfusions, and in severe cases, a full hysterectomy. Accordingly, it is desirable to control such postpartum bleeding, if possible, at its onset. The cause of postpartum hemorrhage, in approximately 80% of cases, is uterine atony, which is the inability of the woman's uterus to contract after delivering the child. Risk factors for uterine atony include prolonged staged of labor, preeclampsia, and multiparity.
The original technology for treating postpartum hemorrhage was oxytoxic agents, hormonal agents that induce muscle contraction. Unfortunately, studies have increasingly shown that oxytoxic agents do not significantly reduce either the incidence of postpartum hemorrhage or the amount of blood lost. Some studies have even indicated that oxytoxic agents are being over used to the point that this treatment increases the risk of uterine atony.
Other approaches have been taken, such as medical devices. U.S. Pat. No. 4,552,557 discloses a inflatable intrauterine device that inflates intrauterinely, acting a tamponade to stop blood flow. Because this device expands when inflated, this device and method do not facilitate uterine contraction. U.S. Patent Publication No. 2011/0087337 discloses a generic organ contraction device for controlling the flow of fluid in a lumen formed by a tissue wall of a patient's organ, however this device does not use suction to contract the organ. Finally, U.S. Patent Publication No. 2011/0172569 discloses a surgical vacuum device that uses a suction cup to tamponade specific surfaces of an organ. However, the suction cup is not capable of contracting a uterus.
Dr. Christopher B. Lynch has developed a technique for surgically removing the uterus, wrapping the uterus in sutures, and pulling on these sutures to contract the uterus. Although this approach has been effective at arresting postpartum hemorrhage this method is extremely invasive and potentially very harmful to the patient. What is needed is a device that can contract a postpartum uterus in a non-invasive manner.